Expertise in Computer System Validation (CSV) aligned with FDA 21 CFR Part 11, GAMP 5, ICH Q9, and other global regulatory frameworks.

Comprehensive quality assurance covering V-model lifecycle, including validation planning, risk assessments, test protocol development, execution, and traceability.

Specialized experience with clinical systems, lab informatics (LIMS, ELN), manufacturing execution systems (MES), pharmacovigilance, and electronic submissions.

Ensuring systems meet GxP standards (GLP, GMP, GCP) and are always audit-ready for FDA, EMA, and global regulatory inspections.

Integration of modern QA tools for manual and automated testing, including tools like ALM, Jira, TestRail, Selenium, and Tosca.

Scalable, cost-effective Validation-as-a-Service model tailored for fast-paced product and software deployments in life sciences.

Flexible delivery options with access to SMEs and validated resource pools trained specifically in healthcare & life sciences protocols.